Cardiac Biomarkers in Early Detection of Cardiotoxicity in Patients Receiving Sunitinib or Sorafenib Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-12

Study Completion Date

2018-05-02

Brief Summary

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This trial studies how well cardiac biomarkers work in the early detection of cardiotoxicity in patients receiving sunitinib malate or sorafenib chemotherapy. Some chemotherapies are known to cause damage to heart muscle cells, resulting in heart failure. Often, the damage is not detected until heart failure has already occurred. Testing for cardiac biomarkers, such as troponin I and/or T and B-type natriuretic peptide (BNP), may be useful in detecting heart damage earlier than other tests currently performed (such as echocardiogram and electrocardiogram).

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Detailed Description

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PRIMARY OBJECTIVES:

I. To determine if specific biomarkers (troponin I and B-type natriuretic peptide \[BNP\]) detect cardiotoxicity earlier than standard clinical means in patients receiving sunitinib malate (SU11248) or sorafenib chemotherapy.

SECONDARY OBJECTIVES:

I. To prospectively evaluate the incidence and severity of cardiac toxicity related to sunitinib or sorafenib during chemotherapy.

OUTLINE:

Patients receive sunitinib malate or sorafenib chemotherapy then undergo blood collection 2 weeks later, and then every 4-6 weeks for up to 6 months to test for troponin I and BNP.

Conditions

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Malignant Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ancillary-correlative (biospecimen collection)

Patients receive sunitinib malate or sorafenib chemotherapy then undergo blood collection 2 weeks later, and then every 4-6 weeks for up to 6 months to test for troponin I and BNP.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo collection of blood

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient age 18-85 years
* Starting a new course of chemotherapy at MD Anderson Cancer Center that includes sunitinib or sorafenib
* Has a life expectancy of greater than 6 months

Exclusion Criteria

* Unstable angina within the last 3 months
* Myocardial infarction within the last 3 months
* Left ventricular ejection fraction (LVEF) less than 40%
* Decompensated heart failure (HF) in the last 3 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No